Minimally invasive mitral valve repair method and apparatus

ABSTRACT

The present invention is directed to an apparatus and method for the stabilization and fastening of two pieces of tissue. A single device may be used to both stabilize and fasten the two pieces of tissue, or a separate stabilizing device may be used in conjunction with a fastening device. The stabilizing device may comprise a probe with vacuum ports and/or mechanical clamps disposed at the distal end to approximate the two pieces of tissue. After the pieces of tissue are stabilized, they are fastened together using sutures or clips. One exemplary embodiment of a suture-based fastener comprises a toggle and suture arrangement deployed by a needle, wherein the needle enters the front side of the tissue and exits the blind side. In a second exemplary embodiment, the suture-based fastener comprises a needle connected to a suture. The needle enters the blind side of the tissue and exits the front side. The suture is then tied in a knot to secure the pieces of tissue. One example of a clip-based fastener comprises a spring-loaded clip having two arms with tapered distal ends and barbs. The probe includes a deployment mechanism which causes the clip to pierce and lockingly secure the two pieces of tissue.

CROSS REFERENCE TO RELATED PATENT APPLICATIONS

The present application is a continuation of co-pending U.S. applicationSer. No. 10/423,046, filed Apr. 24, 2003, entitled “Minimally InvasiveMitral Valve Repair Method and Apparatus,” which is a continuation ofU.S. application Ser. No. 09/562,406, filed May 1, 2000, entitled“Minimally Invasive Mitral Valve Repair Method and Apparatus,” now U.S.Pat. No. 6,626,930, which claimed priority under 35 U.S.C. § 19(e) fromU.S. Provisional Patent Application No.: 60/161,296, filed Oct. 21,1999, entitled “Minimally Invasive Mitral Valve Repair Method AndApparatus.” The disclosure of both the Parent and Provisional patentapplication are incorporated by reference herein in its entirety.

FIELD OF THE INVENTION

The present invention relates to the repair of heart valves, and, moreparticularly, to methods and apparatuses for the repair of heart valvesby fastening the valve leaflets together at their coapting edges.

BACKGROUND OF THE INVENTION

In vertebrate animals, the heart is a hollow muscular organ having fourpumping chambers: the left and right atria and the left and rightventricles, each provided with its own one-way outflow valve. Thenatural heart valves are identified as the aortic, mitral (or bicuspid),tricuspid and pulmonary valves. The valves separate the chambers of theheart, and are each mounted in an annulus therebetween. The annulusescomprise dense fibrous rings attached either directly or indirectly tothe atrial and ventricular muscle fibers. The leaflets are flexiblecollagenous structures that are attached to and extend inward from theannuluses to meet at coapting edges. The aortic and tricuspid valveshave three leaflets, while the mitral and pulmonary valves have two.

Various problems can develop with heart valves, for a number of clinicalreasons. Stenosis in heart valves is a condition in which the valves donot open properly. Insufficiency is a condition which a valve does notclose properly. Repair or replacement of the aortic or mitral valves aremost common because they reside in the left side of the heart wherepressures and stresses are the greatest. In a valve replacementoperation, the damaged leaflets are excised and the annulus sculpted toreceive a replacement prosthetic valve.

In many patients who suffer from valve dysfunction, surgical repair(i.e., “valvuloplasty”) is a desirable alternative to valve replacement.Remodeling of the valve annulus (i.e., “annuloplasty”) is central tomany reconstructive valvuloplasty procedures. Remodeling of the valveannulus is typically accomplished by implantation of a prosthetic ring(i.e. “annuloplasty ring”) to stabilize the annulus and to correct orprevent valvular insufficiency that may result from a dysfunction of thevalve annulus. Annuloplasty rings are typically constructed of aresilient core covered with a fabric sewing ring. Annuloplastyprocedures are performed not only to repair damaged or diseased annuli,but also in conjunction with other procedures, such as leaflet repair.

Mitral valve regurgitation is caused by dysfunction of the mitral valvestructure, or direct injury to the mitral valve leaflets. A less thanperfect understanding of the disease process leading to mitral valveregurgitation complicates selection of the appropriate repair technique.Though implantation of an annuloplasty ring, typically around theposterior aspect of the mitral valve, has proven successful in a numberof cases, shaping the surrounding annulus does not always lead tooptimum coaptation of the leaflets.

More recently, a technique known as a “bow-tie” repair has beenadvocated. The bow-tie technique involves suturing the anterior andposterior leaflets together in the middle, causing blood to flow throughthe two side openings thus formed. This process was originally developedby Dr. Ottavio Alfieri, and involved placing the patient onextracorporeal bypass in order to access and suture the mitral valveleaflets.

A method for performing the bow-tie technique without the need forbypass has been proposed by Dr. Mehmet Oz, of Columbia University. Themethod and a device for performing the method are disclosed in PCTpublication WO 99/00059, dated Jan. 7, 1999. In one embodiment, thedevice consists of a forceps-like grasper device that can be passedthrough a sealed aperture in the apex of the left ventricle. The twomitral valve leaflets meet and curve into the left ventricular cavity attheir mating edges, and are thus easy to grasp from inside theventricle. The mating leaflet edges are grasped from the ventricularside and held together, and various devices such as staples are utilizedto fasten them together. The teeth of the grasper device are linearlyslidable with respect to one another so as to align the mitral valveleaflets prior to fastening. As the procedure is done on a beatingheart, and the pressures and motions within the left ventricle aresevere, the procedure is thus rendered fairly skill-intensive.

There is presently a need for an improved means for performing thebow-tie technique of mitral valve repair.

SUMMARY OF THE INVENTION

The present invention provides a number of devices and methods forfastening or “approximating” tissue pieces together. The term “tissuepieces” is to be understood to mean discrete pieces that may bestraight, curved, tubular, etc., so long as the pieces are initiallydisconnected. For example, many of the embodiments of the inventiondisclosed herein are especially useful for joining two leaflets of aheart valve. The coapting edges of the leaflets thus constitute the“tissue pieces.” In other contexts, the invention can be used toanastomose two vessels, either end-to-end, in a T-junction, orotherwise. In these cases, the two vessels define the “tissue pieces.”One specific application of using the invention to perform ananastomosis is in a coronary artery bypass graft (CABG) procedure.Another example of an application of the present invention is in woundclosure, wherein the facing edges of the wound are joined. In sum, thepresent invention in its broadest sense should not be construed to belimited to any particular tissue pieces, although particular examplesmay be shown and disclosed.

The present invention includes a number of devices and method for bothstabilizing the tissue pieces to be joined, and fastening them together.Some embodiments disclose only the stabilizing function, others only thefastening function, and still other show combination stabilizing andfastening devices. It should be understood that certain of thestabilizing devices can be used with certain of the fastening devices,even though they are not explicitly shown in joint operation. In otherwords, based on the explanation of the particular device, one of skillin the art should have little trouble combining the features of certainof two such devices. Therefore, it should be understood that many of thestabilizing and fastening devices are interchangeable, and the inventioncovers all permutations thereof.

Furthermore, many of the fastening devices disclosed herein can bedeployed separately from many of the stabilizing devices, and the twocan therefore be deployed in parallel. Alternatively, and desirably,however, the fastening and stabilizing functions are performed with onedevice.

The stabilizing and fastening devices of the present invention can beutilized in either standard open surgical procedures, endoscopicprocedures, or percutaneous procedures. In one embodiment the devicescan be delivered through an open chest either transapically ortransatrially. In another embodiment, the stabilizing and fasteningdevices can be introduced through an incision performed over the roof ofthe left atrium. In yet another embodiment the devices can be deliveredinto the left ventricle through the right chest via a thorascope. Thedevices can also be delivered percutaneously, via a catheter orcatheters, into the patient's arterial system (e.g. through the femoralor brachial arteries). Other objects, features, and advantages of thepresent invention will become apparent from a consideration of thefollowing detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an exemplary tissue stabilizer of thepresent invention that uses a vacuum;

FIG. 1 a is an elevational view of a first step in a valve repairprocedure using the tissue stabilizer of FIG. 1;

FIG. 1 b is an elevational view of a second step in a valve repairprocedure using the tissue stabilizer of FIG. 1;

FIG. 2 is a perspective view of a further tissue stabilizer of thepresent invention that also uses a vacuum;

FIG. 2 a is an elevational view of a step in a valve repair procedureusing the tissue stabilizer of FIG. 2;

FIGS. 3 a-3 c are perspective views of several embodiments ofvacuum-based tissue stabilizers having tissue separating walls;

FIG. 3 d and 3 e are sectional views of two different vacuum portconfigurations for the tissue stabilizers shown in FIGS. 3 a-3 c, thestabilizers shown in operation;

FIG. 4 a is an elevational view of a first step in a valve repairprocedure using a mechanical tissue stabilizer with linearlydisplaceable tissue clamps;

FIG. 4 b is an elevational view of a second step in a valve repairprocedure using the tissue stabilizer of FIG. 4 a;

FIG. 4 c is a detailed perspective view of a clamp of the tissuestabilizer of FIG. 4 a extended to grasp a valve leaflet from bothsides;

FIG. 5 a is a perspective view of a suture-based tissue fastener of thepresent invention having toggles;

FIG. 5 b is a sectional view of the suture-based tissue fastener of FIG.5 a loaded into a delivery needle;

FIG. 6 a-6 c are elevational views of several steps in a valve repairprocedure using a tissue stabilizer of the present invention and thesuture-based tissue fastener shown in FIG. 5 a.

FIG. 7 a is a perspective view of an exemplary tissue stabilizing andfastening device of the present invention that uses a vacuum and needlesto deliver suture-based fasteners having toggles through the tissue;

FIG. 7 b is an elevational view of a step in a valve repair procedureusing the tissue stabilizing and fastening device of FIG. 7 a;

FIG. 8 is an elevational view of an alternative tissue stabilizing andfastening device similar to that shown in FIG. 7 a;

FIG. 9 a is a perspective view of a further tissue stabilizing andfastening device of the present invention that uses a vacuum and needlesto deliver suture-based fasteners having toggles through the tissue;

FIG. 9 b is a plan view of the distal tip of the device of FIG. 9 a;

FIGS. 10 a-10 c are several photographs of tissue being connected withsuture-based fasteners having toggles;

FIGS. 11 a-11 c are elevational views of a tissue stabilizing andfastening device of the present invention having members deployable on ablind side of the tissue being connected;

FIGS. 12 a-12 e are elevational views of a tissue stabilizing andfastening device of the present invention having needles deployable on ablind side of the tissue being connected and a suture-based fastener;

FIG. 13 a is a perspective view of a further tissue stabilizing andfastening device of the present invention that uses a vacuum anddeployable needles to deliver suture-based fasteners through the tissue;

FIG. 13 b is a plan view of the distal tip of the device of FIG. 13 a;

FIGS. 14 a-14 b are elevational view of a still further tissuestabilizing and fastening device of the present invention that usesvacuum and deployable needles to deliver suture-based fasteners throughthe tissue;

FIGS. 15 a-15 h are elevational and plan views of several steps in avalve repair procedure using the tissue stabilizing and fastening deviceof FIG. 14;

FIGS. 16 a-16 c are sectional views of several steps in a tissue joiningprocedure using an exemplary tissue stabilizing and fastening devicehaving needles for delivering a suture-based fastener;

FIG. 16 d is a detailed perspective view of a portion of the device seenin FIG. 16 b;

FIGS. 16 e and 16 f are isolated views of suture ties used with thesuture-based fastener of FIG. 16 a;

FIGS. 17 a-17 c are elevational views of several steps in a valve repairprocedure using an exemplary tissue stabilizing and fastening device fordelivering a suture-based axial needle fastener;

FIG. 18 a is an elevational view of a first step in a valve repairprocedure using an exemplary tissue fastening device of the presentinvention for delivering a spiral suture-based leaflet fastener;

FIG. 18 b is a detailed perspective view of a second step in a valverepair procedure using the spiral suture-based leaflet fastener of FIG.18 a;

FIG. 18 c is an elevational view of a completed valve repair procedureutilizing the spiral suture-based leaflet fastener of FIG. 18 a;

FIG. 18 d is a detailed view of a pledget anchoring device used with thespiral suture-based leaflet fastener of FIG. 18 a;

FIGS. 19 a-19 d are elevational views of several steps in a valve repairprocedure using an exemplary tissue stabilizing and fastening device ofthe present invention having vacuum stabilization and mechanicalclamping;

FIG. 20 is an elevational view of a mechanical tissue stabilizer withpivoting tissue clamps;

FIGS. 21 a and 21 b are elevational views of two steps in a valve repairprocedure using the mechanical tissue stabilizer of FIG. 21;

FIGS. 22 a and 22 b are elevational views of two steps in a valve repairprocedure using a mechanical tissue stabilizer of the present inventionhaving preformed hooks;

FIG. 22 c is a detailed perspective view of a hook of the tissuestabilizer of FIG. 22 a extended to grasp a valve leaflet from the sideopposite the tissue stabilizer;

FIGS. 23 a and 23 b are elevational views of two steps in a valve repairprocedure using a mechanical tissue stabilizer of the present inventionhaving spring-biased hooks;

FIG. 23 c is a detailed perspective view of two hooks of the tissuestabilizer of FIG. 23 a extended to grasp the valve leaflets from theside opposite the tissue stabilizer;

FIGS. 24 a-24 d are elevational views of several steps in a valve repairprocedure using a mechanical tissue stabilizer of the present inventionto deliver a non-suture-based fastener;

FIG. 25 a is a perspective view of an exemplary tissue staple usefulwith the methods and devices of the present invention and shown in anopen configuration;

FIG. 25 b is a perspective view of the tissue staple of FIG. 25 a shownin a closed configuration;

FIGS. 26 a-26 c are elevational views of several steps in a valve repairprocedure using an exemplary tissue fastening device of the presentinvention for delivering the tissue staple of FIG. 25 a;

FIG. 27 a is a perspective view of a further tissue stabilizing andfastening device of the present invention that uses a vacuum anddelivers a staple to fasten tissue pieces;

FIG. 27 b is a sectional view of a step in a valve repair procedureusing the tissue stabilizing and fastening device of FIG. 27 a;

FIG. 27 c is a perspective view of a completed valve repair procedureutilizing the tissue stabilizing and fastening device of FIG. 27 a;

FIG. 28 a is an elevational view of a further tissue fastening device ofthe present invention for delivering an alternative “toggle-like” tissueclip, the clip shown open;

FIG. 28 b is an elevational view of the tissue fastening device of FIG.28 a, the clip shown closed;

FIG. 29 a is a detailed perspective view of a first step in a valverepair procedure using the tissue fastening device of FIG. 28 a;

FIGS. 29 b and 29 c are elevational views of two steps in a valve repairprocedure using the tissue fastening device of FIG. 28 a;

FIG. 30 a is a perspective view of an alternative “toggle-like” tissuefastening clip, the clip shown open;

FIG. 30 b is a perspective view of the tissue fastening clip of FIG. 30a shown closed;

FIGS. 31 a-31 d are elevational views of several steps in a valve repairprocedure using an exemplary tissue fastening device of the presentinvention for delivering the tissue fastening clip of FIG. 30 a;

FIGS. 32 a-32 d are elevational views of various tissue fastening clipshaving barbed ends;

FIGS. 33 a and 33 b are sectional views of a two steps in a valve repairprocedure using an exemplary tissue fastening device of the presentinvention for delivering a barbed tissue fastening clip of FIG. 32 a;

FIG. 33 c is an elevational view of a third step in a valve repairprocedure using the tissue fastening device of FIG. 33 a;

FIG. 34 a-34 f are elevational and perspective views of a tissuefastener of the present invention having spring-loaded jaws;

FIG. 35 a is a sectional view of a tissue fastening device fordelivering the tissue fastener of FIG. 34 a;

FIGS. 35 b and 35 c are sectional views of the tissue fastener of FIG.34 a in both closed and opened positions around the tissue beingconnected;

FIGS. 36 a-36 c are elevational views of a further tissue fastener ofthe present invention having spring-loaded jaws;

FIG. 37 a is a sectional view of a tissue fastening device fordelivering the tissue fastener of FIG. 36 a;

FIG. 37 b is a sectional view of the tissue fastener of FIG. 36 a in aclosed position around the tissue being connected;

FIG. 38 is a perspective view of an exemplary integrated tissuestabilizer and fastening device of the present invention;

FIG. 39 is a perspective view of the device of FIG. 38 wherein theneedle carrier is extended;

FIG. 40 is a perspective view of the device of FIG. 38 showing theinitial release of the needles;

FIG. 41 is a perspective view of the device of FIG. 38 showing theneedles captured within the vacuum ports;

FIG. 42 is an exploded view of various components of the device of FIG.38;

FIG. 43 is a perspective view of the device of FIG. 38 wherein theneedle carrier has been removed to clearly show the vacuum ports;

FIG. 44 is a perspective view of an exemplary embodiment of a handpiecethat is utilized with the device of FIG. 38;

FIGS. 45 a and 45 b illustrate perspective views of alternate sutureconfigurations used to practice the invention; and

FIG. 46 is a perspective view of another exemplary embodiment of ahandpiece that is utilized with the device of FIG. 38.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Exemplary Stabilizing Devices

FIG. 1 shows a tissue stabilizer 20 of the present invention that uses avacuum to hold two tissue pieces. In this case, the tissue pieces areheart valve leaflets 22 and a valve repair procedure using thestabilizer 20 is depicted in FIGS. 1 a and 1 b. The tissue stabilizer 20comprises a cylindrical probe 24 with at least one internal lumen (notshown) and having a flat distal end 26, a pair of vacuum ports 28 beingdisposed in the distal end 26. The ports 28 may be in communication witha common vacuum source, may be separately communicable with the sourcewith internal valves (not shown), or may be in communication withdifferent vacuum sources. The size of the ports 28 and magnitude ofsuction applied may vary depending on the application, but the ports 28are desirably spaced apart a minimum distance to create two distinctsuctions. In this manner, one leaflet or the other may be stabilizedwith one of the ports 28 without unduly influencing the other. In oneexample, the ports 28 have a minimum diameter of about ⅛ inch, and arespaced apart with a wall of at least 0.020 inches therebetween.

The probe 24 desirably has a size suitable for minimally invasivesurgery. In one embodiment probe 24 is part of a catheter basedpercutaneous delivery system. In that case probe 24 is a catheter tubehaving a lumen or lumens connecting vacuum ports 28 to the vacuum sourceor sources. The catheter would be long enough and have sufficientsteerability and maneuverability to reach the heart valve from aperipheral insertion site, such as the femoral or brachial artery. Oneparticular advantage of the present invention is the ability to performvalve repair surgery on a beating heart. The procedure shown in FIGS. 1a and 1 b is a mitral valve repair with an approach of the probe 24 fromthe left atrium 30. The atrium 30 has lower pressures than the ventricle31, and thus there is less blood leakage and less turbulence imparted tothe probe 24. First, the anatomical structures, including the locationof the leaflets 22, can be visualized using echo technology, or othermeans. One leaflet 22 may be stabilized with one of the ports 28, andthat leaflet 22 then manipulated toward the other leaflet 22, which isthen also stabilized. Again, any of the fasteners disclosed herein maythen be used to secure the leaflets 22 together.

FIG. 2 is illustrates another tissue stabilizer 32 similar to that shownin FIG. 1 and that also uses a vacuum. The tissue stabilizer 32 includesa probe body 34 having at least one internal lumen (not shown) and anangled or tapered nose 36 on a distal end. A vacuum port 38 is providedon each face of the tapered nose 36. FIG. 2 a shows a valve repairprocedure using the tissue stabilizer 32 of FIG. 2, wherein a distal tip40 of the nose 36 is exposed to the ventricular 31 side of the leaflets22. Because of this exposure, various leaflet fastening devices can bedelivered through the probe 34 to the ventricular side of the leaflets22, as will be seen below.

FIGS. 3 a-3 c show three vacuum-based tissue stabilizers having tissueseparating walls. In FIG. 3 a, a tissue stabilizer 40 includes a flatdistal face 42 having a pair of distally-directed tissue separatingwalls 44 extending therefrom, and defining a gap 46 therebetween. Thestabilizer 40 contains one or more lumens in communication with vacuumports 48 that open on both sides of the walls 44. There are four suchports 48 shown, one on each side of each wall 44. In addition, afastener channel 50 opens at the distal face 42 between the walls 44,and facing the gap 46 therebetween. The fastener channel 50 can be usedto deliver tissue fasteners, as described below.

In FIG. 3 b, a tissue stabilizer 52 includes a flat distal face 54having a single distally-directed tissue separating wall 56 extendingtherefrom. The stabilizer 52 contains one or more lumens incommunication with circular vacuum ports 58 that open on both sides ofthe wall 56. There are two such ports 58 shown, one on each side of eachwall 56.

In FIG. 3 c, a tissue stabilizer 60 includes a flat distal face 62having a single distally-directed tissue separating wall 64 extendingtherefrom. The stabilizer 60 contains one or more lumens incommunication with semi-circular vacuum ports 66 that open on both sidesof the wall 64. There are two such ports 66 shown, one on each side ofeach wall 64.

FIG. 3 d and 3 e show two different vacuum port configurations for thetissue stabilizers 40, 52, or 60 shown in FIGS. 3 a-3 c. As mentionedabove, the stabilizers 40, 52, or 60 may have one or more lumens incommunication with one or more ports. In FIG. 3 d, two lumens 68 a and68 b provide separate suction control to the associated ports. Thus, onetissue piece 70 a is seen stabilized by the right-hand vacuum port,while the left-hand port is not operated. Alternatively, a single lumen72 in communication with two vacuum ports is seen in FIG. 3 e, and bothtissue pieces 70 a, 70 b are stabilized simultaneously. In both theseviews, the tissue separating wall 74 is shown between the tissue piecesto be joined. Fastening devices can thus be delivered via the wall 74,or through a gap formed for that purpose, such as the gap 46 andfastener channel 50 seen in FIG. 3 a.

FIGS. 4 a-4 c show a mechanical tissue stabilizer 80 with a four-part,linearly displaceable tissue clamp 82. On each side, a lower clamp 84 isseparated from an upper clamp 86 and inserted between two tissue pieces(in this case valve leaflets 22). As the lower and upper clamps 84, 86are brought together, as seen in FIG. 4 b, they physically clamp andstabilize the leaflet 22. Small teeth 88 on the clamps 84, 86 may beprovided for traction. The clamps 84 and 86 on each side areindividually actuated to enable grasping of one leaflet 22 at a time.

Exemplary Suture-Based Tissue Fasteners

FIG. 5 a illustrates a suture-based tissue fastener 90 of the presentinvention including toggles 92 secured to the end of suture threads 94.FIG. 5 b is a sectional view through a needle 96 used to deliver thetissue fastener 90. Specifically, the toggle 92 and suture thread 94 isseen loaded into the lumen of the needle 96, and a pusher 98 is providedto urge the tissue fastener 90 from the distal end thereof.

FIG. 6 a-6 c depict several steps in a valve repair procedure using thetissue fasteners 90 shown in FIG. 5 a. A probe, such as the probe 20seen in FIG. 1 having vacuum ports for tissue stabilization, provideslumens for two of the needles 96 of FIG. 5 b. The lumens with the vacuumparts 96 may receive the needles 96 or additional lumens may beprovided. The sharp ends of the needles 96 pierce the leaflets, and thepushers 98 are displaced (separately or in conjunction) to deploy thetissue fasteners 90. After the needles 96 are retracted, the toggles 92anchor the tissue fasteners 90 on the ventricular 31 side of theleaflets 22. The suture threads 94 are then tied off on the atrial 30side to secure the leaflets 22 together, as seen in FIG. 6 c.

FIG. 7 a is a perspective view of an exemplary tissue stabilizing andfastening device 100 that uses the principles of vacuum stabilizationand a suture-based toggle fastener, as seen in FIGS. 5 a and 5 b. Thedevice 100 includes a probe 102 defining several lumens (not shown)therein that open on a distal face. Two lumens 104 open at a proximalend and receive two of the needles 96 for delivering the fasteners. Twoother lumens communicate through two side arms 106 with sources ofvacuum. FIG. 7 b shows the device 100 in use in a valve repairprocedure, with the two needles 96 having pierced the leaflets 22 anddelivered the fasteners 90. The leaflets 22 are held to the probe 102using the vacuum ports.

FIG. 8 illustrates an alternative tissue stabilizing and fasteningdevice 108 similar to the device 100 of FIG. 7 a, but having a pointednose with two concave faces 110 in which the vacuum ports are located.The device 108 functions as described above, with a fastener deliverneedle shown in phantom having pierced the left leaflet 22.

FIGS. 9 a and 9 b show a still further tissue stabilizing and fasteningdevice 112 that uses a vacuum and needles to deliver suture-basedfasteners having toggles through the tissue. The device 112 is quitesimilar in function to the device 102 of FIG. 7 a, but has a modifieddistal end, as best seen in the plan view of FIG. 9 b. Specifically, acentral tissue separating wall 114 is provided with a pair of vacuumports 116 a on one side, and another pair 116 b on the other. Again, theport 116 may be separately or commonly supplied with vacuum. Fastenerdelivery lumens 118 a and 118 b are located on each side of the wall.The aforementioned needles 96 or other such device may be deliveredthrough the lumens 118 to pierce and fasten the tissue pieces.

FIGS. 10 a-10 c are several photographs of tissue being connected withsuture-based fasteners having toggles. FIG. 10 a illustrates the toggle92 being deployed. FIG. 10 b illustrates the needles 96 being retracted,and FIG. 10 c illustrates the sutures 94 being tied.

FIGS. 11 a-11 c show a tissue stabilizing and/or fastening device 120having members deployable on a blind side of the tissue being connected.In this context, “blind side” means the side of the tissue piecesopposite the side to which the device has direct access. The deployablemembers may be clamps to stabilize the tissue pieces, or fasteningdevices that contact the tissue pieces on the blind side.

The device 120 includes a probe 122 with lumens, and a distal tip 123that is narrower than the probe 122 and defines concave transition faces124. A vacuum port 126 may be provided in each transition face 124 fortissue stabilization, or a clamping mechanism may be stowed in a space128 in the distal tip 123. FIG. 11 c shows the clamp 129 (or fastener)in a deployed state.

FIGS. 12 a-12 e illustrate a tissue stabilizing and fastening device 130having needles 132 deployable on a blind side of the tissue beingconnected. The device 130 may be configured like the device 120 of FIG.11 a, with the space 128 receiving needles 132. A common suture thread134 connects the needles 132 and is used to secure the tissue pieces 70together. Thus, as seen in the sequence of FIGS. 12 a-12 e, the needles132 are first advanced to the blind side of the tissue pieces 70 anddeployed outboard of the distal tip. The entire device 130 is retracted,as in FIG. 12 c, to cause the needles 132 to pierce the tissue pieces70. The two needles 132 are then disengaged from the device 130, andeach other, as in FIG. 12 d, and the entire device 130 once againretracted to pull the needles 132 out from the pieces 70, leaving theconnected suture joining the two pieces 70 (FIG. 12 e). The suture 132can then be tied off, or otherwise secured on the upper side of thetissue pieces 70.

FIG. 13 a is a more detailed view of a tissue stabilizing and fasteningdevice 140 similar to that shown in FIGS. 12 a-12 e. The device 140features two semi-circular vacuum ports 142 that stabilize the tissuepieces being joined. The distal tip includes a centered anddistally-directed frame 144 defining a space 146 therein. The needles148 are connected to the frame 144 and reside within the space 146.Although not shown, a deployment mechanism is also provided that causesthe needles to pivot outward about their distal ends, and alsodisengages the needles 148 from the frame 144.

FIGS. 14 a-14 b illustrate a tissue stabilizing and fastening device 150having needles 152 deployable on a blind side of the tissue beingconnected. The device 150 includes a probe 154 having two vacuum ports156 a, 156 b for stabilizing the tissue pieces 70 being joined. A distaltip includes an extension member 158 having a centered anddistally-directed frame 160 defining a space 162 therein. The extensionmember 158 may be configured relatively narrow in one direction suchthat it can enter the ventricle 31 between the leaflets 22 with minimumrisk to the chordae (not shown). The frame 160 may be extended andretracted within the probe 154. The needles 152 are connected to theframe 160 and reside within the space 162. A deployment mechanism (notshown) is provided that causes the needles 152 to pivot outward abouttheir distal end, and also disengages the needles 152 from the frame160. A common suture thread 166, which is stored within the probe 154,connects the needles 152 and is used to secure the tissue pieces 70together. In the embodiment shown in FIG. 14, the device 150 includestwo needles 152 and a single suture 166. Other embodiments may includefour needles with separate sutures. Additional needles may be providedif needed.

FIGS. 15 a-15 h illustrate several steps in a tissue joining procedureusing the tissue stabilizing and fastening device 150. Referring to FIG.15 a, the probe 154 is passed through the atrium 30 via an accesscannula or catheter 164. During this stage, the frame 160 is in itsretracted position. The probe 154 is secured to the atrium 30 with apurse string 166 or any other manner known to one skilled in the art.FIGS. 15 b-15 d illustrate stabilization of the leaflets 22 beingjoined. Suction is provided to the first vacuum port 156 a, and theprobe 154 is manipulated to capture the first leaflet 22. With the firstleaflet 22 captured, suction is provided to the second vacuum port 156b, and the second leaflet 22 is captured. Referring to FIG. 15 e, theframe 160 is advanced into the ventrical 31 by extending the frame 160,and the needles 152 pivot outward about their distal end. The frame 160is returned to its retracted position, and the needles 152 pierce theleaflets 22 and are directed into needle receivers 168, as shown in FIG.15 f. As shown in FIG. 15 g, suction to the vacuum ports 156 a, 156 b isterminated, and the leaflets 22 are released. The needle receivers 168pull the needles 152 through the leaflets 22, and the suture 166“pays-out” behind the needles 152. The suture 166 trails out as theprobe 154, with the needles 152 stored within the probe 154, iswithdrawn from the access cannula or catheter 144 (see FIG. 15 g). Thetwo needles 152 are then disengaged from the probe 154, and the suture166 can then be tied off, or otherwise secured on the upper side of theleaflets 22.

FIGS. 16 a-16 c are sectional views of several steps in a tissue joiningprocedure using a tissue stabilizing device 170 having a fasteningdevice 172 with two needles 174 for delivering a suture-based fastener.The stabilizing device 170 includes a distal tip with oppositely-facingconcave surfaces 176 for contacting and stabilizing the tissue pieces 70(with, e.g., vacuum ports). Although not shown, the fastening device 172is stowed in a channel within the stabilizing device 170 and may belinearly deployed through apertures formed in the concave surfaces 176.

The device 170 further includes a sliding plate 178 with twothroughholes 180 in the distal end, as seen in FIG. 16 d. The fasteningdevice 172 has a spring bias that causes the needles 174 to curve inwardwhen permitted. Therefore, as seen in FIG. 16 b, the fastening device172 has been freed from the channels past the concave surfaces 176 andthe needles 174 have curved inward to be received in the plate holesthroughholes 180. The needles 174 first pass twice through eachrespective tissue piece 70. The plate 178 is then retracted upward intothe device 1170, thus pulling the needles 174 through the tissue pieces70. The fastening device 172 is desirably made of a highly pliablematerial, such as a superelastic like Nitinol, so that it can be pulledthrough sharp angles. Suture threads 182 are connected to each needle174 and are also pulled through the tissue pieces 70. FIG. 16 c showsthe result, with the suture thread 182 passed through both tissue pieces70. FIGS. 16 e and 16 f illustrate two suture ties to complete theprocedure.

FIGS. 17 a-17 c illustrate several steps in a valve repair procedureusing a tissue stabilizing and fastening device 190 for delivering asuture-based axial needle fastener 192. The device 190 includes aclamping mechanism 194, much like the clamping device 82 seen in FIGS. 4a-4 c. The two sides are independently controllable, so as to grasp andpierce one leaflet 22 and then the other. The fastener 192 includes apair of needles 196 initially mounted in the lower portion of theclamping mechanism 194 and facing upward. The two needles 196 areconnected with a suture thread 198. When the clamping mechanism 194actuates, the needles 198 pierce the respective leaflet 22. The upperportion of each side then pulls the needle 196 completely through theleaflet 22, and the lower portion is retracted from the blind side ofthe leaflets 22. The resulting suture loop is tied off, as seen in FIG.17 c.

FIGS. 18 a-18 d illustrate a valve repair procedure using a tissuefastening device 200 and a spiral suture-based leaflet fastener 202. Theleaflets 22 are stabilized, using one of the means disclosed herein(such as suction from two angled faces 204), and the fastener 202 isdeployed. The fastener 202 comprises a helical needle 206, a trailingsuture thread 208, and a pair of pledget anchoring devices 210. FIG. 18d is a detailed view of the pledget 210 used with the spiralsuture-based leaflet fastener 202.

FIGS. 19 a-19 d illustrate a tissue stabilizing and fastening device 220that uses the principles of vacuum stabilization/mechanical clamping anda suture-based toggle fastener. The device 220 includes a probe 222having two vacuum ports for initial tissue stabilization. In addition tothe vacuum ports 224, the device 220 includes a mechanical tissuestabilizer 226 with a four-part, rotatable and linearly extendablecapture hooks 228. The distal tip includes a centered anddistally-directed frame 230 defining a space 232 therein. The capturehooks 228 are folded flat within the space 232 and are rotatably andslidingly coupled to the probe 222 so that the capture hooks 228 may berotated about 90 degrees and retracted to a capture position, whereinthe leaflets 22 are “pinched” between distal ends of the capture hooks228 and shoulders 234 of the probe 222. The two vacuum ports 224 alsoprovide lumens for two of the needles 96 of FIG. 5 b. The sharp ends ofthe needles 96 pierce the leaflets 22, and the pushers 98 are displaced(separately or in conjunction) to deploy the tissue fastener 90. Afterthe needles 96 are retracted, the toggles 92 anchor the tissue fasteners90 on the ventricular 31 side of the leaflets. The suture threads 94 arethen tied off on the atrial 30 side to secure the leaflets 22 together,as seen in FIG. 6 c.

FIGS. 19 a-19 d illustrate several steps in a valve repair procedureusing the tissue stabilizing and fastening device 220. The stabilizingand/or fastening elements of the device 220 is formed relatively narrowin one dimension to enable it to be slipped between the two leaflets 22,wherein the capture hooks 228 are stored in a folded and extendedposition. The two leaflets 22 are initially stabilized by the vacuumports 224. To further stabilize the leaflets 22, the capture hooks 228are rotated 90 degrees and retracted, wherein the leaflets 22 arephysically clamped against the shoulders 234 of the probe 222 and thedistal ends of the capture hooks 228. It is noted that both vacuumstabilization and mechanical clamping do not have to be implemented tostabilize the leaflets 22. In certain applications, implementing onlyone of the mechanisms may be desireable. With the leaflets 22 properlystabilized, the needles 96 are driven forward to pierce the leaflets 22.The capture hooks 228 reduce the likelihood of losing grasp of theleaflets 22 during the piercing process. As shown in FIG. 5 b, thepushers 98 are displaced (separately or in conjunction) to deploy thetissue fastener 90. After the needles 96 are retracted, the toggles 92anchor the tissue fasteners 90 on the ventricular 31 side of theleaflets 22. The suture threads 94 are then tied off on the atrial 30side to secure the leaflets 22 together, as shown in FIG. 6 c.

Exemplary Mechanical Stabilizers and Fasteners

FIG. 20 shows a mechanical tissue stabilizer 240 that can be used tograsp tissue pieces 70 to be joined. The stabilizer 240 includes a probe242 having a pair of pivoting arms 244 on a distal end. The arms 244each have teeth 246 for added purchase on the tissue. FIGS. 21 a and 21b illustrate a valve repair procedure initiated in accordance with thepresent invention using the tissue stabilizer 240.

FIGS. 22 a and 22 b illustrate steps in a valve repair procedure using amechanical tissue stabilizer 250 having preformed hooks 252. The hooks252 are curled into approximately a three-quarter circle and deployed onthe blind side of the leaflets 22 to grasp and stabilize them. Thelinear displacement of each hook 252 is separately controllable.

FIGS. 23 a-23 c illustrate steps in a valve repair procedure using amechanical tissue stabilizer 260 having spring-biased hooks 262. Thehooks 262 curl into approximately a three-quarter circle when deployed,and are advanced on the blind side of the leaflets 22 to grasp andstabilize them. Again, the linear displacement of each hook 252 isseparately controllable.

FIGS. 24 a-24 d illustrate a valve repair procedure using a mechanicaltissue stabilizer 270 similar to both the stabilizers shown in FIGS. 22and 23. After hooks 272 have stabilized the leaflets 22, a retainer 274is slid down link rods 276 of each hook 272 (FIG. 24 c). FIG. 24 d showsthe retainer 274 having reached the curvature of the hooks 272, at whichpoint the link rods 276 are severed using conventional means. Forexample, the link rods 276 may be made of a polymer material, and acutter deployed adjacent the device 270 to sever them. Again, the linkrods 276 are separately displaceable as seen in FIG. 24 b.

Exemplary Staple and Clip-Type Fasteners

FIG. 25 a shows an exemplary tissue staple 280 for joining two tissuepieces in an open configuration. The staple 280 includes a bridgeportion 282 and four gripping arms 244, two on each side. The grippingarms 284 are initially curled in a semi-circle upward from the plane ofthe bridge portion 282 and terminate in sharp points approximately inthe plane of the bridge portion 282. FIG. 25 b shows the staple 280 whenclosed, with the gripping arms 284 curled underneath the plane of thebridge portion 282 toward each other.

FIGS. 26 a-26 c illustrate several steps in a valve repair procedureusing an exemplary tissue fastening device 290 for delivering the tissuestaple 280. The device 290 includes a probe 292 with an internal lumen294 within which a pusher 296 is slidable. A stop member 298 is alsoprovided underneath the bridge portion 282 of the staple 280 to preventdisplacement of the bridge portion 282 toward the leaflets 22. Afterstabilizing the leaflets 22, the pusher 296 displaces downward whichcauses the staple 280 to undergo a plastic deformation from theconfiguration of FIG. 25 a to that of FIG. 25 b. The sharp points of thegripping arms 284 pass through the leaflets 22 and anchor the staple 280therein. Finally, the stop member 298 is disengaged from under thebridge portion 282, and the device 290 is retracted.

FIG. 27 a illustrate the use of a tissue stabilizing and fasteningdevice 300 for deploying the staple 280 of FIG. 25. The device 300 isquite similar to the device 290 of FIG. 26, with an exemplarystabilizing means shown in the form of vacuum chamber(s) 302 on eachside of the staple deployment mechanism.

FIGS. 28 a and 28 b illustrate a further tissue fastening device 310 ofthe present invention for delivering an alternative “toggle-like” tissueclip 312. In FIG. 28 a the clip 312 is shown open, while in FIG. 28 bthe clip 312 is shown closed. The clip 312 is plastically deformed fromopen to close using a clamping mechanism 314 that flattens a ring-shapedhead portion 316 of the clip 312. Two pincher arms 318 thus pivot towardeach other and grasp and hold tissue therebetween.

FIGS. 29 a-29 c depict steps in a valve repair procedure using thetissue fastening device 310 of FIG. 28. One method for inserting thedevice 310, as well as many other devices of the present invention,between the two leaflets 22 is detailed in FIG. 29 a. Specifically, thestabilizing and/or fastening elements of the devices of the presentinvention can be formed relatively narrow in one dimension to enablethem to be slipped between two tissue pieces so that the pieces can thenbe fastened together from the blind side. Thus, for example, the tissuefastening device 310 is seen in FIG. 29 a rotated to orient the narrowdimension in line with the gap between the leaflets 22.

FIGS. 30 a-30 b and 31 a-31 d illustrate an alternative tissue fasteningdevice 320 for delivering another “toggle-like” tissue fastening clip322. In contrast to the clip 312 of FIG. 28, the clip 322 pierces thetissue pieces 70 from the front side, and is then deformed to clamp thetissue pieces 70 together.

FIGS. 32 a-32 d illustrate various embodiments of barbed clips 330, 332,334, 336 used to fasten tissue pieces together using the principles ofthe present invention. The barbed clips include a bridge portion 338,340, 342, 344 and terminate in sharp points.

FIGS. 33 a-33 c illustrate several steps in a valve repair procedureusing an exemplary barbed clip deployment device 350 for delivering thebarbed clip 330. The device 350 includes a probe 352 with an internallumen 354 within which an internal driver 356 is slidable. A stop member358 is provided at the distal end of the probe 352 to spread the twobarbs away from each other as it is pushed forward. The tips of thebarbed clip 330 are displaced towards the leaflets 22 by downwardlysliding the driver 356. After the clip 330 pierces the leaflets 22 fromthe front side, the clip 330 is disengaged from the device 350 as shownin FIG. 33 c. When the clip 330 is disengaged from the device 350, itreturns to its retracted position and compresses the leaflets 22together. Again, any of the stabilizers of the present invention can beused in conjunction with the deployment device 350.

FIGS. 34 a-34 f illustrate a spring-loaded clip 360 used to fastentissue pieces 70 together. The clip 360 comprises a spring portion 362and two arms 364, and the arms 364 include a plurality of barbs 366. Thedistal ends of the arms 364 are tapered to enable the clip 350 to piercethe leaflets 22, and the arms 364 are configured to overlap each otherafter closure (see FIG. 34 c). FIGS. 35 a-35 c illustrate a valve repairprocedure using a clip deployment device 370 for delivering thespring-loaded clip 360. The device 370 includes a probe 372 with aninternal lumen 374, and a pusher 376 is slidably coupled to the internallumen 374. A sleeve 378 is disposed between the pusher 376 and theinternal wall of the lumen 374. The spring portion 362 of the clip 360is housed within the sleeve 378 in its open position, wherein the springportion 362 is compressed by the sleeve 378. As seen in the sequence ofFIGS. 35 a-35 c, downward movement of the pusher 376 causes the clip 360to move downward and pierce the leaflets 22 from the front side. Theclip 360 is pushed downward at a velocity adequate to insure penetrationwithout dislodging the leaflets 22 from the vacuum source. As the clip360 is disengaged from the device 370, the clip 360 automaticallysprings to its closed position and compresses the leaflets together.

FIGS. 36 a-36 c illustrate another embodiment of a spring-loaded clip380 used to fasten tissue pieces together. The clip 380 comprises aspring portion 382 and two arms 384 having distal ends which are taperedand extend inwardly to pierce and lockingly secure the leaflets 22. Agap 386 exits between midportions of the arms 384 when the clip 380 isin its closed position.

FIGS. 37 a and 37 b illustrate a clip deployment device 390 having aprobe 392 with an internal lumen 394 and a pusher 396 slidably coupledto the internal lumen 394. The spring portion 382 is retained in acompressed state within a housing member 398 such that the clip 380 isheld in an open position. Downward movement of the pusher 396 causes theclip 380 to move downward and pierce the leaflets 22 from the frontside. As the spring portion 384 exits the housing member 398, the clip380 automatically springs into its closed position and lockingly securesand compresses the leaflets 22.

Exemplary Integrated Stabilizing and Fastening Device

FIGS. 38-46 illustrate another exemplary embodiment of an integratedtissue stabilizing and fastening device 400 which captures tissuepieces, such as valve leaflets, with vacuum and fastens the tissuepieces with sutures. The device 400 is similar to the devicesillustrated in FIGS. 11-15 in that it comprises a slender distal portionwhich accesses the heart valve trans-atrially. The device 400 is placedthrough a specialized cannula and it has a proximal handpiece portionwhich provides user controls. In an exemplary embodiment the distalportion is approximately 10 mm in diameter and it terminates in vacuumports and a needle array as depicted in FIGS. 38 through 41. Thehandpiece portion contains individual vacuum port controls and needledeployment controls as generally depicted in FIG. 44. The device 400 isconnected to a vacuum source via a flexible hose. The illustrated device400 is utilized to grasp the tissue pieces and place the suturescorrectly. Remote tying and cutting of the sutures can be accomplishedwith a separate device. The following description of the use of thedevice 400 will be made with respect to the stabilizing and fastening ofthe leaflets of a mitral valve. However, those of skill in the art willappreciate that the device can also be used to stabilize and fastenother physiological tissues. A more detailed description of the device400 follows.

FIGS. 38-41 illustrate device 400 in various modes of operation. Device400 comprises vacuum ports 402 and 404 at the distal tip of device 400which are connected to the vacuum source 418 (shown in FIG. 44). Needlecarrier 406 is centrally disposed at the distal end of device 400 and isconfigured to be extended from and retracted back into device 400.Needles 408 are mounted on mounting blocks 410 within carrier 406 andmounting blocks 410 are pivotably attached to carrier 406 via pivot pin412. Needle catchers 414 are retained in ports 402 and 404 to grip andretain needles 408 when needle carrier is retraced back into device 400upon completion of the procedure.

FIG. 44 illustrates an exemplary handpiece 416 which connects vacuumsource 418 to device 400 and delivers vacuum to vacuum ports 402, 404 atthe distal tip of the device. Pinch valves 420 mounted on the handpiece416 of the device normally constrict the vacuum lines. By individuallymanipulating each valve, the operator can differentially control accessto the vacuum source. By partially deflecting one valve, the operatorpermits momentary access by one of the vacuum ports to the vacuumsource. By fully deflecting one of the valves, the operator permitscontinuous access to the vacuum source. The provision of separate,individually controlled valves permits the delivery of differentialvacuum to one or the other of ports 402 and 404. This may be veryhelpful in certain cases of valve prolapse where it is necessary tocapture one leaflet and move it laterally with respect to the secondleaflet to facilitate final capture.

The vacuum system has, of necessity, two different operating modes.Initially, it is necessary to capture the leaflets. This requiresrelatively high flow rates to attract a leaflet to a vacuum port. In anexemplary embodiment the flow rate is approximately 10 cc per second.Since this flow rate is capable of exsanguinating and destabilizing thebeating heart, the invention provides for quick and efficient leafletcapture. Efficient capture requires that the vacuum port be close to theleaflet when the vacuum is turned on. Proper placement of device 400with respect to the leaflets is facilitated by placement of echogenicmembers at or near vacuum ports 402 and 404 to enhance visualization byecho.

Echogenicity is enhanced by the proper choice of materials. The device,being entirely of plastic except for small metal parts in the immediatevicinity of the ports, takes advantage of the relatively high visibilityof metal while avoiding the shadowing properties of large masses ofmetal. The metal parts in question are needle catchers 414, needles 408and pivot pin 412. Since these parts are located near the vacuum ports402 and 404 in the long axis of the device, they serve to locate ports402 and 404 axially relative to the valve leaflets prior to vacuumapplication. Since they are discontinuous and symmetrical about ports402 and 404 in the short axes, they facilitate the correct radialorientation of the ports relative to the valve leaflets. Echogenicity isfurther enhanced by a polymer coating which can be wholly or selectivelyapplied to the ports 402 and 404. This coating creates a microscopicboundary layer which effectively separates the ports from the bloodunder echo visualization.

In an exemplary embodiment, the vacuum surfaces of the ports 402 and 404are angled between zero and ninety degrees relative to a plane normal tothe long axis of the device. This is intended to conform somewhat to theshape of the valve leaflets. In another exemplary embodiment the portsare angled between 15 to 40 degrees relative to a plane normal to thelong axis of the device. In yet another embodiment the ports are angledat about 25 degrees relative to that plane.

Once the leaflets have been captured, the second operating mode of thevacuum system is to hold the leaflets in position for suture applicationwithout additional exsanguination. This implies high holding force andno flow. These properties are primarily a function of pressuredifferential, port area and port shape. In one embodiment, adequateholding force is obtained at a maximum differential pressure with portareas in the approximate range of 0.03-0.04 square inch per port. In theembodiment illustrated in FIG. 43, a geometrically optimized cylindricaldevice is shown having two separate “D” shaped ports 404 and 404. Theillustrated device 400 has about 10 mm in diameter. Since a vacuum portwith the highest ratio of area to perimeter (i.e., a circle) will havethe highest average peel away strength, some modification of the “D”shaped port is useful for functional optimization. This is accomplishedin the device by filling in the corners of the “D” where the arc meetsthe straight portion at acute angles. This can be seen clearly on port402 in FIG. 38. The corners which have been eliminated represent thepart of the “D” shape least resistant to peel away of the leaflet whichis being held by vacuum.

Vacuum ports 402 and 404 further have barriers 422 which serve twodistinct purposes. Barriers 422 support the valve leaflet to prevent itfrom being sucked deep into the ports 402 and 404, thereby minimizingtissue trauma. This has the further useful effect of controlling theposition of the leaflet relative to the suture needles so that thelatter penetrate the leaflet in a predictable way, placing sutures thecorrect distance from the edge of the leaflet for reliable repair. Inthe illustrated embodiment of FIG. 43, the barriers are recessed belowthe perimeter of the “D” slot. In an exemplary embodiment the barriersare recessed about 0.02 inches. This slightly distorts the valve tissueand creates resistance to displacement of tissue as it is movedlaterally by the device to approximate the leaflets. If the barrierswere not recessed, the only resistance to lateral drag would be thecoefficient of friction between the port surface and the leaflet whichis likely to be low in the bloody environment.

A pre-evacuated sterile bottle 418 serves as a passive vacuum source forcapturing and holding the leaflets. In an exemplary embodiment, thesystem is designed to minimize total exsanguination to about 200 cc perprocedure. A standard 2 liter bottle can provide that amount of flowwith negligible increase in absolute pressure. This offers a significantadvantage over utility vacuum sources in hospital operating rooms anddedicated active pumps. Utility sources are not well controlled andactive pumps present cost, convenience and sterility issues.

Once captured, leaflets will be fastened by remotely applied sutures.The mechanism by which this is accomplished is shown in FIGS. 39 through42 as will be discussed below. FIGS. 45 a and 45 b illustrates twoexemplary suture configurations which the system can provide, dependingon the way in which the sutures and needles are loaded into the device.

In one embodiment, two lengths of suture (not shown) are used with astraight needle 408 attached to each suture end. Sutures are insertedinto a coaxial hole in the end of the needle opposite the point and thebody of the needle is crimped to retain the suture using conventionalsuture technology. A groove near the tip of the needle provides a meansfor grasping and pulling the needle through after it has pierced thevalve leaflet. Sutures can be monofilament or braided or other typessuitable for cardiovascular use. In an exemplary embodiment, a size 4-0monofilament suture capable of gamma sterilization (e.g. Novafil) isused since the internal configuration of the device favors radiationsterilization and it is desirable to be able to sterilize the entiresystem at one time. The needles will receive a lubricious coating (e.g.silicone) to reduce penetration force and fraction.

In one embodiment, the needles and sutures are an integral part of asingle use completely disposable device. In a second embodiment, theneedles, sutures and associated hardware may be packaged as a cartridgewhich plugs into a reusable device. This device can be limited tomultiple use in a single procedure, or reusable for multiple procedures.

Needle carrier 406 further comprises needle driver assembly 424. Driverassembly 424 includes blocks 410, axle 412, needle driver 426, and cams428. Needles 408 are slidably mounted in blocks 410 which pivot aboutaxle 412. Blocks 410 may be slotted in the area of the hole whichreceives the needle so that the needles can be held in place bycontrolled friction. Sutures (not shown) protruding from the ends of theneedles can be routed along the sides of the needle carrier 406 ingrooves provided for that purpose. The needles are initially recessedinto the body of the device 400 by virtue of the recessed position ofcarrier 406, as shown in FIG. 38. The position of the needles in thisstate is shown in FIG. 39. The needle mounting blocks 410 are pivoted sothat needles 408 lie in a single row within the confines of the needlecarrier 406. One end of driver element 426 which drives the needlecarrier 406 in and out of the distal device tip is positioned just abovethe needle points so that the needles 408 are retained in their holders410 against any drag which might tend to dislodge them. The other end ofthe driver element 426 is connected to a control at the proximal end ofthe device by which the operator manipulates the needles 408.

After the valve leaflets are captured as described above, needle carrier406 is advanced from the position shown in FIG. 38 to that of FIG. 39.The needle mechanism at this stage is compactly configured to avoidentangling chordae tendineae or papillary muscles during capture of theleaflets and initial needle deployment. Cams 428 are then advanced,pivoting the needle mounting blocks 410 and causing the needles 408 todeploy as shown in FIG. 40. Protruding stops on blocks 410 limit theangular deployment of the needles to the proper position for penetratingthe valve leaflets. These stops come to rest against the needle carrier406. The individual parts can be seen clearly in FIG. 42.

With the needles deployed, the needle carrier 406 is retractedproximally, causing the needle points to penetrate valve leaflets (notshown) and enter the vacuum ports 402 and 404. As the needles continueto move proximally, the points enter the needle catchers 414 which areessentially one way gripping devices. The needles advance until theirgrooves engage the jaws of the needle catchers 414. Needle catchers 414are retained in the ports 402 and 404 by a vacuum adapter 430, shown inFIG. 42.

The needle carrier 406 advances distally pulling the needle mountingblocks 410 away from the needles which are retained by the needlecatchers 414. The vacuum is disconnected and the device is withdrawnfrom the heart along with the needles 408 which are firmly held by thecatchers 414. As the needles move outward, the sutures, which areloosely deployed in the body of the device 400, are pulled through theleaflets 432 and 434 to one of the positions shown in FIGS. 45 a and 45b. Once the device is free of the access cannula, sutures 436 and 438,or 440 and 442, are cut from the needles and tied remotely using a knotrundown tool with an integral cutter to remove excess suture material.

The proximal control handpieces 416 shown in FIGS. 44 and 46 areillustrative of alternate approaches to controlling the system. Oneobjective is to permit single handed control of the vacuum ports andsuture needles without destabilizing the device. It is useful to locateand hold the device precisely in relation to the beating heart in orderto accomplish the surgical procedure with minimal blood loss. Inoperation, the surgeon will use one hand to stabilize the distal end ofthe device via the cannula where it enters the atrium and the other handto operate the vacuum and suturing controls. Control functions aredescribed below.

In the device shown in FIG. 44, handpiece 416 has a pistol-likeconfiguration which includes a shaft portion 446 and a handle portion448. A pair of vacuum controls 420 are positioned akin to pistol hammersat the back of shaft portion 446 and at the top of handle portion 448.In this embodiment vacuum controls 420 are thumb operated. Vacuumcontrols 420 are separately capable of being partially activated orfully activated by a toggle mechanism (not shown). When partiallyactivated, the associated vacuum line is momentarily opened, allowingblood to flow into the vacuum source 418. If one of the controls 420 isreleased it will return to its normally closed position and flow to theassociated line will stop immediately. Once a leaflet has been capturedthe control 420 can be moved to its extreme position where it willremain due to an internal toggle action. In this case vacuum is appliedto retain the leaflet which, in turn, blocks the port, preventing bloodflow.

In another embodiment shown in FIG. 46, the pair of vacuum controls 420are located in the body 416 below the shaft portion 446 and in front ofthe handle portion 448. In this embodiment the vacuum controls 420function like a pistol trigger, just above the needle control trigger444, so that they can be operated individually by the index finger. Inthe arrangement shown, it will be necessary to actuate the controlnearest the index finger first. The first action momentarily opens thevacuum line as described above. When the leaflet is captured the controlis depressed further, causing it to latch into place by an internaltoggle action. The second control 420 is now accessible to the indexfinger for capture of the second leaflet in similar manner.

In the embodiments shown in FIGS. 44 and 46 the trigger 444 is pivotablymounted in body 416 to control needle deployment after the leaflets arecaptured. The trigger is connected to needle driver 426 by a linkageinternal to the body 416 which establishes the correct direction andstroke. The device is supplied with the trigger fully depressed to holdthe needle array in the position shown in FIG. 38 relative to the vacuumports 402 and 404. An internal latch in 416 retains the trigger. Oncethe leaflets have been captured the trigger is released, allowing theneedles to advance to the position shown in FIG. 39. Near the end of thetrigger stroke, needle driver 426 bears on cams 428 which, in turn, bearon blocks 410 causing the needles to deploy outward as in FIG. 40.

Squeezing the trigger 444 moves the needles proximally through the valveleaflets and into the vacuum ports 402 and 404 where they will betrapped as previously described. The trigger stroke will be internallylimited so that it will not achieve the latched condition in which thecycle began. Releasing the trigger moves the needle carrier 406 forward,separating the needles from blocks 410. The entire device can now beremoved, drawing sutures through the leaflets as previously described.The distal tip of the device 400 is rotatable relative to the body 416for precise angular positioning of the ports 402 while maintaining acomfortable handle position for the user.

The present invention may be embodied in other specific forms withoutdeparting from its spirit, and the described embodiments are to beconsidered in all respects only as illustrative and not restrictive. Thescope of the invention is, therefore, indicated by the claims and theirequivalents rather than by the foregoing description.

1. A method of connecting suture to a heart valve having at least twoleaflets, the method using one or more catheters, each catheter having areleasable capturing apparatus configured to releasably capture one ormore heart valve leaflets, each catheter further having a suturedeploying apparatus configured to deploy one or more sutures through oneor more heart valve leaflets, the method comprising; positioning a firstcatheter in a patient's body so that the releasable capturing apparatusand suture deploying apparatus of the first catheter are adjacent afirst heart valve leaflet; releasably capturing the first heart valveleaflet with the releasable capturing apparatus; deploying a firstsuture line through the first heart valve leaflet with the suturedeploying apparatus; deploying a second suture line through the firstheart valve leaflet with the suture deploying apparatus; releasing thefirst heart valve leaflet from the releasable capturing apparatus; anddrawing the first and second suture lines through the first heart valveleaflet.
 2. The method of claim 1, wherein drawing the first and secondsuture lines through the first heart valve leaflet includes withdrawingthe first catheter from the area adjacent the first heart valve leaflet.3. The method of claim 1, wherein the first and second suture lines aredeployed simultaneously through the first heart valve leaflet.
 4. Themethod of claim 1, wherein the first and second suture lines areopposing ends of a first common suture line.
 5. The method of claim 1,further comprising: releasably capturing the second heart valve leaflet;deploying a third suture line through the second heart valve leaflet;deploying a fourth suture line through the second heart valve leaflet;and releasing the second heart valve leaflet; and drawing the third andfourth suture lines through the second heart valve leaflet.
 6. Themethod of claim 5, wherein the first and second suture lines areopposing ends of a first common suture line, and the third and fourthsuture lines are opposing ends of a second common suture line.
 7. Themethod of claim 6, wherein the third and fourth suture lines aredeployed via the first catheter simultaneously with the deployment ofthe first and second suture lines.
 8. The method of claim 7, furthercomprising: securing the first suture line to the third suture line. 9.The method of claim 8, wherein securing the first suture line to thethird suture line comprises remotely tying and advancing a knot tosecure the first suture line to the third suture line.
 10. The method ofclaim 8, further comprising: securing the second suture line to thefourth suture line.
 11. The method of claim 7, further comprising:securing the first suture line, second suture line, third suture line,and fourth suture line together to form a generally x-shaped sutureassembly
 12. A method of connecting suture to a heart valve having atleast two leaflets using a catheter having a releasable capturingapparatus configured to releasably capture one or more heart valveleaflets, the catheter further having a suture deploying apparatusconfigured to deploy one or more sutures through one or more heart valveleaflets, the method comprising; positioning the catheter in a patient'sbody so that the releasable capturing apparatus and suture deployingapparatus are adjacent a first heart valve leaflet; releasably capturingthe first heart valve leaflet with the releasable capturing apparatus;deploying a first suture line through the first heart valve leaflet withthe suture deploying apparatus; positioning the catheter in a patient'sbody so that the releasable capturing apparatus and suture deployingapparatus are adjacent a second heart valve leaflet; releasablycapturing the second heart valve leaflet with the releasable capturingapparatus; deploying a second suture line through the second heart valveleaflet with the suture deploying apparatus; releasing the first heartvalve leaflet and the second heart valve leaflet from the releasablecapturing apparatus; and drawing the first and second suture linesthrough the first and second heart valve leaflets, respectively.
 13. Themethod of claim 12, wherein drawing the first and second suture linesthrough the first and second heart valve leaflets includes withdrawingthe catheter from the area adjacent the first and second heart valveleaflets.
 14. The method of claim 12, wherein the first and secondsuture lines are deployed simultaneously through the first and secondheart valve leaflets, respectively.
 15. The method of claim 12, whereinthe first and second suture lines are opposing ends of a first commonsuture line.
 16. The method of claim 15, further comprising: securingthe first suture line to the second suture line.
 17. The method of claim16, wherein securing the first suture line to the second suture linecomprises tying a knot in the first and second suture lines.
 18. Themethod of claim 12, further comprising: deploying a third suture linethrough the first heart valve leaflet with the suture deployingapparatus; deploying a fourth suture line through the second heart valveleaflet with the suture deploying apparatus.
 19. The method of claim 18,wherein the third and fourth suture lines are deployed simultaneously.21. The method of claim 18, wherein the first and second suture linesare opposing ends of a first common suture line, and the third andfourth suture lines are opposing ends of a second common suture line.22. The method of claim 21, further comprising: securing the firstsuture line to the second suture line, and securing the third sutureline to the fourth suture line.
 23. The method of claim 22, whereinsecuring the first suture line to the second suture line comprisesremotely tying and advancing a first knot to secure the first sutureline to the second suture line, and wherein securing the third sutureline to the fourth suture line comprises remotely tying and advancing asecond knot to secure the third suture line to the fourth suture line.